Ensuring Drug Quality in Global Health Programs

Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC), as well as by providing contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). USAID and CDC implement the President's Emergency Plan for AIDS Relief (PEPFAR), which provides antiretroviral treatment to more than 3.9 million people, and the President's Malaria Initiative (PMI), which has procured and distributed over 67 million malaria treatments. The Global Fund provides antiretroviral drugs to about 3.3 million people, has supported tuberculosis treatment for 8.6 million, and enabled treatment of 170 million malaria cases. Concerns have been raised about the potential for substandard drugs to enter the supply chains of global health programs. Substandard drugs, which may be caused by poor manufacturing practices, improper storage or distribution, or tampering, can have serious public health consequences, including ineffective treatment of diseases, adverse reactions in patients, and drug-resistant strains of pathogens. Given these concerns, the U.S. Government Accountability Office (GAO) was requested to review safeguards in place to ensure drug products procured with U.S. foreign aid funds are of assured quality. USAID, CDC, and the Global Fund have put regulatory and policy requirements in place to help prevent procurement of substandard drugs. USAID reviews quality assurance information for all drugs before they are procured, requiring implementing partners to obtain written approval from the agency before purchasing drugs. Through its approval process, USAID determines whether there is sufficient information available to assure that the drug is of acceptable quality. The Global Fund requires grant recipients to procure antiretroviral, tuberculosis, and malaria drugs that are prequalified by the World Health Organization or authorized by a stringent regulatory authority. Procedures for monitoring drug quality in supply chains used by global health programs vary based on the nature of the program and capacity of implementing partners. USAID takes a case-by-case approach to monitoring drug quality, considering factors such as the vulnerability of drugs to deterioration and the capacity of implementing partners to safeguard them. The Global Fund requires grant recipients to have quality assurance systems in place for procurement, warehousing, product testing, distribution, and monitoring of storage and distribution sites, and to ensure that drugs are randomly tested at different points in the supply chain. A recent USAID initiative aims to increase drug procurement and supply by host governments and local organizations. However, reliance on these implementing partners potentially introduces risks related to capacity and corruption. USAID is taking measures to mitigate these risks by conducting country assessments to identify risks to drug quality, program outcomes, and financial management, and by taking steps to develop risk mitigation plans with implementing partners before funding malaria and reproductive health programs.